Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer

NCT ID: NCT03819088

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-17

Study Completion Date

2022-03-22

Brief Summary

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This randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc deficiency.

Detailed Description

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PRIMARY OBJECTIVE:

I. Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.

SECONDARY OBJECTIVES:

I. Correlate hypoalbuminemia with serum zinc deficiency.

II. Correlate zinc deficiency with neutropenia.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive zinc orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy.

GROUP II: Patients receive zinc orally (PO) TID for months 3 and 4 only of the first 4 months on therapy.

Conditions

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Gastric Carcinoma Liver and Intrahepatic Bile Duct Carcinoma Unresectable Esophageal Carcinoma Unresectable Pancreatic Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (zinc months 1 and 2)

Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.

Group Type EXPERIMENTAL

Zinc

Intervention Type DIETARY_SUPPLEMENT

Given PO

Group II (zinc months 3 and 4)

Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.

Group Type EXPERIMENTAL

Zinc

Intervention Type DIETARY_SUPPLEMENT

Given PO

Interventions

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Zinc

Given PO

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Zinc sulfate

Eligibility Criteria

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Inclusion Criteria

* Patients who present to adult medical oncology outpatient clinic with new diagnosis of non-resectable gastric, gastro-esophageal, pancreas or biliary cancer
* Patients plan to receive chemotherapy at an Emory Cancer Center
* No prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer
* Patients must sign informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Olatunji Alese

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olatunji B. Alese, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2017-02467

Identifier Type: REGISTRY

Identifier Source: secondary_id

Winship4173-17

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00099791

Identifier Type: -

Identifier Source: org_study_id

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